A clinical and ethical review on late results and benefits after EVAR

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Abstract

Introduction

The aim of this review is to assess if late mortality after endovascular repair (EVAR) of abdominal aortic aneurysms (AAA) is a real problem, and whether it could be an issue in the case of medical litigation.

Material and methods

A review of all English language literature was performed on PubMed web-site, looking for all papers reporting EVAR long-term mortality rate. EVAR performances were reviewed also from an ethical and medico-legal point of view, based on current Italian laws.

Results

Mono-centric studies, and international registers suggest that today EVAR offers similar (if not better) results than open repair (OR) in the treatment of AAAs with standard and complex anatomies, even if performed outside the devices-specific instructions for use. In contrast, large randomized trials, and consequently current guidelines, suggest that EVAR still has an ancillary role compared to OR, only to be used for highly selected patients.

Recently, specific litigation cases on surgical options related to the treatment of aortic aneurysms has developed. The informed consent process needs to include not only mortality and major complications related to the procedure but also the chance of patients' outcomes. For those reasons, the generic nature of informed consent has been criticized.

Conclusions

No conclusive data is currently available to assess the initial question of late mortality after EVAR but results are still improving. In the meantime, widespread use of EVAR as first choice for treating AAA may only be acceptable in high-volume centres validating their results by a strict follow up protocol.

Highlights

•

The long-term results after endovascular repair (EVAR) for abdominal aortic aneurysms (AAA) are still considered one of the main limitations of this treatment option.
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This paper is a comprehensive review of the current literature on long-term mortality after EVAR procedures.
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An analysis on informed consent for EVAR from a non-surgical point of view is reported for the very first time.

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Most cited references 48

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Transfemoral intraluminal graft implantation for abdominal aortic aneurysms.

J C Parodi, J Palmaz, H D Barone (1991)

This study reports on animal experimentation and initial clinical trials exploring the feasibility of exclusion of an abdominal aortic aneurysm by placement of an intraluminal, stent-anchored, Dacron prosthetic graft using retrograde cannulation of the common femoral artery under local or regional anesthesia. Experiments showed that when a balloon-expandable stent was sutured to the partially overlapping ends of a tubular, knitted Dacron graft, friction seals were created which fixed the ends of the graft to the vessel wall. This excludes the aneurysm from circulation and allows normal flow through the graft lumen. Initial treatment in five patients with serious co-morbidities is described. Each patient had an individually tailored balloon diameter and diameter and length of their Dacron graft. Standard stents were used and the diameter of the stent-graft was determined by sonography, computed tomography, and arteriography. In three of them a cephalic stent was used without a distal stent. In two other patients both ends of the Dacron tubular stent were attached to stents using a one-third stent overlap. In these latter two, once the proximal neck of the aneurysm was reached, the sheath was withdrawn and the cephalic balloon inflated with a saline/contrast solution. The catheter was gently removed caudally towards the arterial entry site in the groin to keep tension on the graft, and the second balloon inflated so as to deploy the second stent. Four of the five patients had heparin reversal at the end of the procedure. We are encouraged by this early experience, but believe that further developments and more clinical trials are needed before this technique becomes widely used.

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Outcomes following endovascular vs open repair of abdominal aortic aneurysm: a randomized trial.

Dolores Cikrit, K Swanson, Gloria H Y Lin … (2009)

Limited data are available to assess whether endovascular repair of abdominal aortic aneurysm (AAA) improves short-term outcomes compared with traditional open repair. To compare postoperative outcomes up to 2 years after endovascular or open repair of AAA in a planned interim report of a 9-year trial. A randomized, multicenter clinical trial of 881 veterans (aged > or = 49 years) from 42 Veterans Affairs Medical Centers with eligible AAA who were candidates for both elective endovascular repair and open repair of AAA. The trial is ongoing and this report describes the period between October 15, 2002, and October 15, 2008. Elective endovascular (n = 444) or open (n = 437) repair of AAA. Procedure failure, secondary therapeutic procedures, length of stay, quality of life, erectile dysfunction, major morbidity, and mortality. Mean follow-up was 1.8 years. Perioperative mortality (30 days or inpatient) was lower for endovascular repair (0.5% vs 3.0%; P = .004), but there was no significant difference in mortality at 2 years (7.0% vs 9.8%, P = .13). Patients in the endovascular repair group had reduced median procedure time (2.9 vs 3.7 hours), blood loss (200 vs 1000 mL), transfusion requirement (0 vs 1.0 units), duration of mechanical ventilation (3.6 vs 5.0 hours), hospital stay (3 vs 7 days), and intensive care unit stay (1 vs 4 days), but required substantial exposure to fluoroscopy and contrast. There were no differences between the 2 groups in major morbidity, procedure failure, secondary therapeutic procedures, aneurysm-related hospitalizations, health-related quality of life, or erectile function. In this report of short-term outcomes after elective AAA repair, perioperative mortality was low for both procedures and lower for endovascular than open repair. The early advantage of endovascular repair was not offset by increased morbidity or mortality in the first 2 years after repair. Longer-term outcome data are needed to fully assess the relative merits of the 2 procedures. clinicaltrials.gov Identifier: NCT00094575.

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Endovascular aneurysm repair and outcome in patients unfit for open repair of abdominal aortic aneurysm (EVAR trial 2): randomised controlled trial.

David Epstein (2015)

Endovascular aneurysm repair (EVAR) to exclude abdominal aortic aneurysm (AAA) was introduced for patients of poor health status considered unfit for major surgery. We instigated EVAR trial 2 to identify whether EVAR improves survival compared with no intervention in patients unfit for open repair of aortic aneurysm. We did a randomised controlled trial of 338 patients aged 60 years or older who had aneurysms of at least 5.5 cm in diameter and who had been referred to one of 31 hospitals in the UK. We assigned patients to receive either EVAR (n=166) or no intervention (n=172). Our primary endpoint was all-cause mortality, with secondary endpoints of aneurysm-related mortality, health-related quality of life (HRQL), postoperative complications, and hospital costs. Analyses were by intention to treat. 197 patients underwent aneurysm repair (47 assigned no intervention) and 80% of patients adhered to protocol. The 30-day operative mortality in the EVAR group was 9% (13 of 150, 95% CI 5-15) and the no intervention group had a rupture rate of 9.0 per 100 person years (95% CI 6.0-13.5). By end of follow up 142 patients had died, 42 of aneurysm-related factors; overall mortality after 4 years was 64%. There was no significant difference between the EVAR group and the no intervention group for all-cause mortality (hazard ratio 1.21, 95% CI 0.87-1.69, p=0.25). There was no difference in aneurysm-related mortality. The mean hospital costs per patient over 4 years were UK pound sterling 13,632 in the EVAR group and pound sterling 4983 in the no intervention group (mean difference pound sterling 8649, SE 1248), with no difference in HRQL scores. EVAR had a considerable 30-day operative mortality in patients already unfit for open repair of their aneurysm. EVAR did not improve survival over no intervention and was associated with a need for continued surveillance and reinterventions, at substantially increased cost. Ongoing follow-up and improved fitness of these patients is a priority.

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Author and article information

Journal

Journal ID (nlm-ta): Ann Med Surg (Lond)

Journal ID (iso-abbrev): Ann Med Surg (Lond)

Title: Annals of Medicine and Surgery

Publisher: Elsevier

ISSN (Electronic): 2049-0801

Publication date PMC-release: 20 February 2017

Publication date Collection: April 2017

Publication date (Electronic): 20 February 2017

Volume: 16

Pages: 1-6

Affiliations

[a ]Vascular and Endovascular Surgery Unit, Department of Medicine, Surgery and Neuroscience, University of Siena, Italy

[b ]Vascular and Endovascular Surgery Unit, Department of Surgery “Paride Stefanini”, “Sapienza” University of Rome, Italy

[c ]Department of Anatomical, Histological, Forensic and Orthopaedic Sciences, “Sapienza” University of Rome, Italy

[d ]Neuromed, Istituto Mediterraneo Neurologico (IRCCS) di Pozzili, Italy

[e ]School of Laws, University of Camerino, Italy

Author notes

[∗ ]Corresponding author.

Article

Publisher ID: S2049-0801(17)30034-1

DOI: 10.1016/j.amsu.2017.02.006

PMC ID: 5328746

SO-VID: acd13d65-8bf0-4fb6-a4a8-93440e524486

License:

This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

History

Date received : 6 December 2016

Date revision received : 16 February 2017

Date accepted : 16 February 2017

A clinical and ethical review on late results and benefits after EVAR

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Abstract

Introduction

Material and methods

Results

Conclusions

Highlights

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Most cited references 48

Transfemoral intraluminal graft implantation for abdominal aortic aneurysms.

Outcomes following endovascular vs open repair of abdominal aortic aneurysm: a randomized trial.

Endovascular aneurysm repair and outcome in patients unfit for open repair of abdominal aortic aneurysm (EVAR trial 2): randomised controlled trial.

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